Luster Now

Description

Luster Now_DEN1055 is presented in two packaging formats: a box and a tube. The product is designed for professional use, ensuring optimal delivery and application. The box contains the necessary components for effective utilization, while the tube provides a convenient means of dispensing the formulation. Each format is engineered to maintain the integrity and efficacy of the product during storage and use.

Uses and Indications

This drug is indicated for the prevention of dental caries as an anti-cavity agent.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children 12 years of age and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. It is important to ensure that the product is not swallowed during use. The product is not recommended for use by children under 12 years of age.

Contraindications

Use is contraindicated in children under 12 years of age. This precaution is necessary to prevent potential harm, as the safety and efficacy of the product have not been established in this population. Additionally, the product should be kept out of reach of children to avoid accidental ingestion or misuse.

Warnings and Precautions

In the event that an excessive amount of the product, beyond what is typically used for brushing, is accidentally ingested, immediate medical assistance should be sought or a poison control center contacted without delay.

Care should be taken to avoid any contact of the product with the eyes. Should irritation manifest, characterized by symptoms such as redness, swelling, or soreness of the gums or mouth, it is imperative to discontinue use of the product and consult a dentist for further evaluation and management.

Side Effects

In clinical use, patients may experience various adverse reactions associated with the product. Serious warnings include the necessity for immediate medical assistance or contact with a poison control center if more than the recommended amount used for brushing is accidentally swallowed. Additionally, it is crucial to avoid contact of the product with the eyes to prevent potential harm.

Common adverse reactions may manifest as irritation, which can present as redness, swelling, or soreness of the gums or mouth. In such cases, patients are advised to discontinue use of the product and consult a dentist for further evaluation and management.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Luster Now (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product, as it is not recommended for this age group. It is advised to keep the product out of reach of children under 12 years. For patients aged 12 years and older, the recommended usage is to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. It is important to note that the product should not be swallowed.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been specifically established. There are no available data regarding the potential risks or fetal impacts associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to weigh the potential benefits against any unknown risks. It is recommended that healthcare providers discuss the implications of medication use during pregnancy with their patients, ensuring informed decision-making.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data regarding its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters have not been defined.

Overdosage

In the event of an overdosage, it is critical to seek immediate medical assistance or contact a poison control center if more than the recommended amount used for brushing is accidentally swallowed.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage situations. Symptoms may vary depending on the specific substance involved, and therefore, a thorough assessment of the patient's condition is necessary.

Management procedures should include monitoring the patient for any adverse effects and providing supportive care as needed. It is advisable to have the product's labeling and any relevant medical history available when contacting medical professionals or poison control for guidance.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children under 12 years. It is important to emphasize the potential risks associated with accidental ingestion by young children and to ensure that patients understand the necessity of proper storage to prevent such incidents.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product within a temperature range of 59-80°F (15-27°C) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable environment to prevent degradation.

Additional Clinical Information

The product is administered via the dental route. For optimal results, patients are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Luster Now, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)